On behalf of the American Urological Association (AUA), representing 10,000 urologists in the United States, I am pleased to submit comments on the proposed changes to require all hospitals, long-term care facilities, ambulatory surgery centers (ASCs) and other Medicare-certified facilities to meet the provisions of the 2000 edition of the National Fire Protection Association's Life Safety Code ("LSC"). This issue is important to many urologists who have ownership interests and/or perform surgical procedures in ambulatory surgical centers throughout the United States.

The Centers for Medicare and Medicaid Services (CMS) is to be commended for its ongoing effort to promote patient safety in every environment where health care services are delivered. The AUA shares this deep concern for the safety of patients and employees in ASCs and we recognize the efforts of CMS and its predecessor HCFA over the past several years toward this goal.

As you know, the proposed regulations would require all ASCs to meet the provisions applicable to "ambulatory health care centers", in addition to rules of general applicability. Under the proposed rule, facilities would be required to adopt the 2000 edition of the Life Safety Code (LSC) as a standard. According to the October 26, 2001 Federal Register, ASCs have been previously required to meet the 1981 or 1985 edition of LSC, unless they were JCAHO accredited, in which case they were required to meet the 1997 edition. There would be no grandfathering of existing facilities. Some requirements of the 2000 edition of the LSC are substantially different from earlier editions. Among the new requirements that facilities would have to meet are the following:

Facilities would be required to install emergency lighting that illuminates escape routes for 1.5 hours. This would require retrofitting and replacing batteries that meet the previous standards. There would be a three year phase-in period for this requirement to allow for normal battery replacement cycles. CMS estimates this cost to be $600 per light.

Any renovations would require compliance with new construction standards when possible, including the installation of sprinklers in non-sprinklered buildings. CMS estimates the additional costs to install sprinklers in a non-sprinklered building undergoing renovations to be $2.50 per square foot. No definitions are offered about what constitutes renovations in the view of CMS.

Facilities would be required to protect vertical openings (e.g., stairwells) such that fire and toxic gases cannot spread from one level to another. This would require extensive renovations in facilities that previously were up to existing standards, again with no grandfathering provisions. Estimated cost would be $2,938 per opening.

Facilities would be required to install fire alarm systems that notify local fire and emergency forces automatically. Estimated cost would be $900 per facility.

Areas in non-sprinklered buildings must be separated from a corridor by fire-rated corridor walls. Cost to upgrade a facility to meet this requirement is estimated at $7,124. It is unclear if the installation of a fire-rated wall would be defined as a "renovation". If so, said renovation would then trigger installation of sprinklers. The unclear language in the proposed rule makes this decision tree a "Catch-22."

All ASCs would be required to have a Type I Essential Electrical System (EES). Currently, compliant with Medicare standards, many ASCs have a Type III EES. Both types of system require a source of emergency power. However, the differences in the duration that the emergency power source is required to last and the wiring specifications and outlets required are more extensive in Type 1. Informed estimates from electrical engineers indicate the additional cost per operating room to upgrade to Type I would be between $30,000 and $50,000. We feel that the current standards provide more than adequate time for the surgeon to safely discontinue a case should an electrical emergency arise, and the cost of replacing battery powered emergency power supplies with generators to meet these new standards is unnecessary.

These proposed rules, if finalized as drafted, could require devastating retrofit expenditures for ASCs as well as other providers. The following example was provided me by one of our members who is owner of an ASC:

"I looked into getting sprinklers in certain areas of the building and the cost estimate there alone was in excess of $30,000.00, not including the need for a separate water meter for the fire system. This cost, coupled with the other required changes such as the corridor walls would be staggering. We have a 13,000 square foot facility that would have to be renovated. I feel that older structures which follow the older regulations need to be brought up to speed but newer buildings, following more up to date regulations and construction should be assessed on a individual basis."

We urge CMS to modify these proposed rules to allow that existing facilities would not be required to comply with the 2000 LSC standards unless and until renovations were undertaken that would be budgeted in excess of $100,000 in a calendar year. At this level of expenditure, financing opportunities could be available to cover these expensive upgrades to a small facility to comply with the latest version of the LSC, and renovations of this magnitude would normally be expected to disrupt the provision of services in an active facility anyway. To allow the rules to become final without such a grandfathering provision will pose an enormous financial burden on small facilities that provide extremely valuable services to patients in their respective communities. These smaller facilities would be forced to make these investments with little hope of the future recovery of these capital expenditures.

As an alternative, we suggest that CMS add specific waivers or exceptions to the cost prohibitive requirements listed above for ASCs as a special class of covered facility. Since ASCs do not typically perform procedures of the risk or duration of hospital-based procedures, the risks that the improved standards were designed to reduce are not present.

We remain willing to work with CMS in arriving at a solution to the quandary that where patient safety issues are concerned, one size does not fit all.